Search Thermo Fisher Scientific
Search Thermo Fisher Scientific
FDA guidance is intended to help manufacturers meet the requirements in the Agency's current good manufacturing practice (CGMP) regulations (21 CFR parts 210 and 211) when manufacturing sterile drug and biological products using aseptic processing. In the guidance document, Sterile Drug Products Produced by Aseptic Processing—Current Good Manufacturing Practice, the FDA clearly identifies genotypic methods of microbial identification to be more accurate and precise than traditional biochemical and phenotypical techniques.
MicroSEQ ID is designed to support the recommended qualification guidelines from:
Explore strategies in the implementation and validation of microbial identification systems in the CGMP environment and a solution to address any potential challenges.
Helping you validate your system quickly and efficiently, the IQ/OQ Service provides qualification of the fully integrated MicroSEQ Rapid Microbial Identification System, including documentation.
This service offers:
Need help with lab design, setup, and technician training? The MicroSEQ ID Implementation Program helps customize laboratory design and provides workflow training to meet the specific needs of your lab, including:
No matter your questions, we are here to help. Our experienced team of scientists and technical specialists is ready to assist you in choosing the right solution and products. Complete this form to start the conversation.
Explore the Analytics Knowledge Hub and discover a robust collection of webinars, articles, eBooks, infographics, and other digital resources to help you optimize analytical testing in your bioprocess workflow.
Enhance your bioprocessing knowledge with educational content to help you understand issues, solve problems, and make solid decisions.
Deep dive into a targeted collection of scientific application notes, case studies, posters, white papers and more for bioprocessing.
Learn, evaluate, connect.
Connect with a Bioprocessing representative or request more info.
For Research Use Only. Not for use in diagnostic procedures.